Regulatory Breakdown

Regulatory Breakdown
Author: Cary Coglianese
Publisher: University of Pennsylvania Press
Total Pages: 290
Release: 2012-08-16
Genre: Political Science
ISBN: 0812207491

Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation brings fresh insight and analytic rigor to what has become one of the most contested domains of American domestic politics. Critics from the left blame lax regulation for the housing meltdown and financial crisis—not to mention major public health disasters ranging from the Gulf Coast oil spill to the Upper Big Branch Mine explosion. At the same time, critics on the right disparage an excessively strict and costly regulatory system for hampering economic recovery. With such polarized accounts of regulation and its performance, the nation needs now more than ever the kind of dispassionate, rigorous scholarship found in this book. With chapters written by some of the nation's foremost economists, political scientists, and legal scholars, Regulatory Breakdown brings clarity to the heated debate over regulation by dissecting the disparate causes of the current crisis as well as analyzing promising solutions to what ails the U.S. regulatory system. This volume shows policymakers, researchers, and the public why they need to question conventional wisdom about regulation—whether from the left or the right—and demonstrates the value of undertaking systematic analysis before adopting policy reforms in the wake of disaster.

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
Author: Stephen M. Kanovsky
Publisher:
Total Pages: 672
Release: 2020-09
Genre: Drugs
ISBN: 9781935065876

FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

Regulation

Regulation
Author: Jerry Brito
Publisher: Mercatus Center at George Mason University
Total Pages: 128
Release: 2012-08-13
Genre: Law
ISBN: 0983607737

Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
Author: Eunjoo Pacifici
Publisher: Academic Press
Total Pages: 292
Release: 2018-06-13
Genre: Medical
ISBN: 0128111569

Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Biologics Development

Biologics Development
Author: Mark P. Mathieu
Publisher: Parexel International Corporation
Total Pages: 328
Release: 1993
Genre: Political Science
ISBN:

Preventing Regulatory Capture

Preventing Regulatory Capture
Author: Daniel Carpenter
Publisher: Cambridge University Press
Total Pages: 531
Release: 2014
Genre: Business & Economics
ISBN: 1107036089

Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.

Standards for Internal Control in the Federal Government

Standards for Internal Control in the Federal Government
Author: United States Government Accountability Office
Publisher: Lulu.com
Total Pages: 88
Release: 2019-03-24
Genre: Reference
ISBN: 0359541828

Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers' Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.

Research Regulatory Compliance

Research Regulatory Compliance
Author: Mark A. Suckow
Publisher: Academic Press
Total Pages: 345
Release: 2015-06-14
Genre: Medical
ISBN: 0124200656

Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. - Provides a "one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models - Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment - Focuses on United States regulations, covering both animal models and human subjects - Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Regulatory State

Regulatory State
Author: Lisa Schultz Bressman
Publisher: Aspen Publishing
Total Pages: 1325
Release: 2019-09-13
Genre: Law
ISBN: 1543815979

The Regulatory State, Third Edition is distinguished by a practical focus on how federal administrative agencies make decisions, how political institutions influence decisions, and how courts review those decisions. With coverage tailored to 1L or upper-level courses on the regulatory state or legislation and regulation, Bressman, Rubin, and Stack use primary source materials drawn from agency rules, adjudicatory orders, and guidance documents to show how lawyers engage agencies. Additionally, this book uses an accessible central example (auto safety) throughout to make the materials cohesive and accessible, and presents legislation with attention to modern developments in the legislative process. The Regulatory State, Third Edition also presents statutory interpretation in useful terms, highlighting the “tools” that courts employ as well as the theories that judges and scholars have offered. New to the Third Edition: Expanded discussion of agency methods of statutory implementation and regulatory interpretation Additional primary source materials Up-to-date examination of political and judicial control of agency action New chapter with a case study of the regulatory process using the main example from the book Professors and students will benefit from: Tools-based approach that highlights the methods of analysis that agencies, courts, and lawyers utilize Use of an accessible central example as a familiar entry point into a complex legal area Primary source materials—agency documents, including notice-and-comment rules, adjudicatory orders, agency guidance, and more Empirical data, normative or theoretical questions, and practical examples